How do clinicians approach these challenges in practice – especially cases in which patients are diagnosed with CML while already pregnant and those who become pregnant during treatment?
Dr Stock:As above, if unplanned pregnancy occurs in a patient with CML, we will discontinue TKI therapy and counsel the patient about the risks of discontinuation in terms of disease progression and about alternative therapies during pregnancy. If the patient is very early in an unplanned pregnancy, we will also discuss the option of pregnancy termination.
Dr Gralow: If a diagnosis of CML occurs in a pregnant patient, there are several things to consider that guide treatment decisions: the disease phase (chronic or blast crisis), the extent of the cancer (what are the white blood cell counts, how fast are they rising, and what is the disease burden), and timing of the pregnancy (when is delivery anticipated). Fortunately, the vast majority of patients present in the chronic phase. For many of these patients, a “watch and wait” approach can be taken, and it can be reasonable to hold off on starting treatment.
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For patients with rapidly rising white blood cell counts or significant symptoms, treatment should generally not be delayed. Pregnancy itself does not alter the disease course of CML, but a treatment delay due to pregnancy in these settings can impact long-term disease control. In these cases, consideration of termination of the pregnancy in order to start treatment is an option. Treatment recommendations should be based on the status of the CML and tailored to the patient’s personal, cultural, and religious wishes.
The reversal of Roe v Wade, via the United States Supreme Court’s decision in the Dobbs v Jackson Women’s Health Organization has obvious implications for patient care in these scenarios.7 How have the newer abortion restrictions affected CML patients thus far?
Dr Stock:Fortunately, I practice in the state of Illinois, where there is not restricted access.
Dr Gralow: We are mainly hearing concerns and questions from members about the impact Dobbs will have on their patients. This includes concerns about maintaining the ability to provide evidence-based care while navigating the complexities of the legal system, given the quickly changing legal landscape and the subsequent ethical and legal concerns across medicine following the Dobbs decision.
What are some of the ongoing efforts and key remaining needs pertaining to this topic?
Dr Stock: Data has demonstrated no harm to the developing fetus if fertilization occurs from a man taking TKI, but the same is not true for women, as TKIs have demonstrated risk of teratogenicity.2 I would like to see continuous registry updates on pregnancy outcomes and CML disease trajectories in women who are managed with TKI discontinuation therapy and observation during pregnancy; TKI discontinuation with an alternative approach, such as interferon management during pregnancy; and disease response in women who have discontinued TKIs and then resumed after delivery.
Finally, there are women who have become pregnant while on TKIs and have not discontinued treatment due to a variety of reasons, including lack of awareness of pregnancy until later in the first trimester or during the second trimester. Updated outcomes of these pregnancies would also be useful.
Dr Gralow: Many cancer treatments can impact a pregnancy, result in miscarriage, or harm the fetus. In those circumstances, pregnancy termination is an important component of high-quality cancer care, and it must remain an option for patients. ASCO will continue to advocate for patient access to all services needed to treat their cancer, including access to and coverage for pregnancy termination and fertility preservation. ASCO will also advocate for policies that allow clinicians to provide high-quality, evidence-based care for patients who are pregnant or might become pregnant during cancer treatment.
References
- Robertson HF, Apperley JF. Treatment of CML in pregnancy. Hematology Am Soc Hematol Educ Program. 2022;2022(1):123-128. doi:10.1182/hematology.2022000330
- Berman E. Family planning and pregnancy in patients with chronic myeloid leukemia. Curr Hematol Malig Rep. 2023;18(2):33-39. doi:10.1007/s11899-023-00689-5
- Abruzzese E, Mauro M, Apperley J, Chelysheva E. Tyrosine kinase inhibitors and pregnancy in chronic myeloid leukemia: opinion, evidence, and recommendations. Ther Adv Hematol. 2020;11:2040620720966120. doi:10.1177/2040620720966120
- Abruzzese E, Aureli S, Bondanini F, et al. Chronic myeloid leukemia and pregnancy: when dreams meet reality. State of the art, management and outcome of 41 cases, nilotinib placental transfer. J Clin Med. 2022;11(7):1801. doi:10.3390/jcm11071801
- National Cancer Institute. SEER cancer stat facts: leukemia – chronic myeloid leukemia. Bethesda, MD. https://seer.cancer.gov/statfacts/html/clyl.html. Accessed April 21, 2023.
- Assi R, Kantarjian H, Keating M, et al. Management of chronic myeloid leukemia during pregnancy among patients treated with a tyrosine kinase inhibitor: a single-center experience. Leuk Lymphoma. 202;62(4):909-917. doi:10.1080/10428194.2020.1849672
- Shuman AG, Aapro MS, Anderson B, et al. Supporting patients with cancer after Dobbs v. Jackson Women’s Health Organization. Oncologist. 2022;27(9):711-713. doi:10.1093/oncolo/oyac165
